(643g) A Template for Investigating NIR Spectroscopy-Based Deviations

Spectroscopy based PAT (Process Analytical Technology) has become an integral part of modern pharmaceutical manufacturing control strategies. This increasing adoption comes with the need for investigation methodologies that are adapted to the complexity of multivariate models in compliance with the cGMP quality systems in place. A framework, based on fishbone analysis, is proposed for conducting investigations related to chemometric models in a commercial manufacturing setting. A combination of multivariate analysis tools, process data and understanding, as well as traditional approaches are used to support the investigations.

The proposed framework improved the investigation efficiency by defining standardized data analysis methods, which ensured a rigorous investigation and reduced the overall investigation completion time. Case studies will be presented to demonstrate the successful implementation of this framework in a continuous pharmaceutical manufacturing environment.